Info

🌱 來自: Hormone-receptor positive (HER2 negative)-of-metastatic breast cancer

MONARCH 2

The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2 A Randomized Clinical Trial

Key Points

• Question
  • Does treatment with abemaciclib plus fulvestrant prolong the overall survival (OS) of patients with hormone receptor (HR)-positive, ERBB2 (formerly HER2)-negative advanced breast cancer who progressed during prior endocrine therapy?
• Findings
  • In the randomized, placebo-controlled MONARCH 2 trial of 669 patients with HR-positive, ERBB2-negative advanced breast cancer, abemaciclib plus fulvestrant significantly improved median OS to 46.7 months compared with 37.3 months for patients receiving placebo plus fulvestrant.
• Meaning
  • The addition of abemaciclib to fulvestrant provided a clinically meaningful median OS benefit of 9.4 months for patients with HR-positive, ERBB2-negative advanced breast cancer that had progressed on endocrine therapy.

TLDR

在一項名為MONARCH 2的Phase 3研究發現：針對已經經歷內分泌治療的荷爾蒙受體陽性、ERBB2陰性晚期乳腺癌患者，使用abemaciclib加fulvestrant相較於僅使用fulvestrant，於中期分析時已達成預先設定的主要結局-調查者評估之 ✖ 無進展生存期，且在重要次要結局-整體生存期方面有顯著提升 (46.7個月 vs 37.3個月；風險比0.757；P值為0.01)

• 此外，使用abemaciclib的副作用安全性良好，且使用該藥物可延遲患者接受下一線化療的時間
• 該研究已在ClinicalTrials.gov註冊 (NCT02107703) 。